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Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)

Primary Purpose

Brain Diseases, Vegetative State, Unconsciousness

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Simplified Evaluation of CONsciousness Disorders (SECONDs)
Sponsored by
Hangzhou Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Diseases focused on measuring coma, disorder of consciousness, behavioral scale, rehabilitation, diagnosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
  • Age: 18-85 years old;
  • No history of other neurological or psychiatric deficits;
  • Ability to speak Chinese fluently;
  • Medical stability (e.g., absence of mechanical ventilation, sedation, infection)

Exclusion Criteria:

  • None

Sites / Locations

  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Patients in coma

Patients in unresponsive wakefulness syndrome

Patients in minimally conscious state

Patients in emerge from the minimally conscious state

Arm Description

Patients in coma were assessed by the SECONDs and CRS-R for five days.

Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.

Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Outcomes

Primary Outcome Measures

Assess the reliability and validity of the Chinese version of the SECONDs
The reliability and validity of the Chinese version of the SECONDs were evaluated by calculating the weighted Cohen's Kappa and Spearman coefficients of the differences between SECONDs and CRS-R in the diagnosis of MCS and UWS patients
Diagnose the level of consciousness in patients through SECONDs and CRS-R
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Simplified Evaluation of CONsciousness Disorders (SECONDs).
Diagnose the level of consciousness in patients through CRS-R
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Coma Recovery Scale-Revised (CRS-R).

Secondary Outcome Measures

Full Information

First Posted
August 1, 2022
Last Updated
August 9, 2022
Sponsor
Hangzhou Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT05496985
Brief Title
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)
Official Title
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .
Detailed Description
To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases, Vegetative State, Unconsciousness, Central Nervous System Diseases
Keywords
coma, disorder of consciousness, behavioral scale, rehabilitation, diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis [17], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
Masking
Outcomes Assessor
Masking Description
Until the end of the protocol, all three assessors were blinded to the scores acquired by the other assessors.
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients in coma
Arm Type
Experimental
Arm Description
Patients in coma were assessed by the SECONDs and CRS-R for five days.
Arm Title
Patients in unresponsive wakefulness syndrome
Arm Type
Experimental
Arm Description
Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.
Arm Title
Patients in minimally conscious state
Arm Type
Experimental
Arm Description
Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.
Arm Title
Patients in emerge from the minimally conscious state
Arm Type
Experimental
Arm Description
Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days.
Intervention Type
Diagnostic Test
Intervention Name(s)
Simplified Evaluation of CONsciousness Disorders (SECONDs)
Intervention Description
All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)
Primary Outcome Measure Information:
Title
Assess the reliability and validity of the Chinese version of the SECONDs
Description
The reliability and validity of the Chinese version of the SECONDs were evaluated by calculating the weighted Cohen's Kappa and Spearman coefficients of the differences between SECONDs and CRS-R in the diagnosis of MCS and UWS patients
Time Frame
Within 10 days
Title
Diagnose the level of consciousness in patients through SECONDs and CRS-R
Description
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Simplified Evaluation of CONsciousness Disorders (SECONDs).
Time Frame
Within 10 days
Title
Diagnose the level of consciousness in patients through CRS-R
Description
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Coma Recovery Scale-Revised (CRS-R).
Time Frame
Within 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days); Age: 18-85 years old; No history of other neurological or psychiatric deficits; Ability to speak Chinese fluently; Medical stability (e.g., absence of mechanical ventilation, sedation, infection) Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Di
Organizational Affiliation
International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anqi Wang
Organizational Affiliation
International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)

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